FDA Adverse Event
Injury
Summary report: N
CODMAN SURGICAL PATTIE
MDR report key: 1040070
·
Received May 7, 2008
Report
- Report Number
- 1226348-2008-00116
- Event Type
- Injury
- Date Received
- May 7, 2008
- Date of Event
- April 8, 2008
- Manufacturer
- CODMAN & SHURTLEFF, INC.
- Product Code
- HBA
- PMA / PMN Number
- K880402
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
AFFILIATE EXPLAINED THAT THERE SHOULD BE 10 PIECES WITHIN A PACK, BUT THERE ARE 11 PIECES WITHIN THE PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN SURGICAL PATTIE | PADDIE, COTTONOID | HBA | CODMAN & SHURTLEFF, INC. | NA | LZ417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |